1. Confidential: Quality Improvement Material Proactive Risk Assessment: Chemotherapy Medication Use Process Chemotherapy QI Committee

2. Confidential: Quality Improvement Material Committee Members Patrick Stiff, MDPatrick Stiff, MD –Medical Director of CBCC Kevin Barton, MDKevin Barton, MD –Hematology/Oncology Marc Borge, MDMarc Borge, MD –Interventional Radiology Mary Brush, APN, AOCNMary Brush, APN, AOCN –Bone Marrow Transplant Barbara Buturusis, RNBarbara Buturusis, RN –Executive Director Cancer Services Tina Cabala, PharmD, BCOPTina Cabala, PharmD, BCOP –Outpatient Oncology Pharmacist Mary Callaghan, RNMary Callaghan, RN –Director CBCC MaryAnn Collatz, RNMaryAnn Collatz, RN –Asst. Manager CBCC Jaime Firkus, RNJaime Firkus, RN –IAsst. Manager BMT Rita Flaska, RN, CPONRita Flaska, RN, CPON –Interim Manager CBCC Linda Flemm, APN, AOCNSLinda Flemm, APN, AOCNS –Clinical Nurse Specialist Donna Fletcher-Gonzalez, RPhDonna Fletcher-Gonzalez, RPh –Inpatient Oncology Pharmacist Teresa Fortenberry, RN, OCNTeresa Fortenberry, RN, OCN –Inpatient Oncology Nurse Kathy Fujiu, RN, OCNKathy Fujiu, RN, OCN –Inpatient Oncology Manager Ellen Gaynor, MDEllen Gaynor, MD –Hematology/Oncology David Hecht, MDDavid Hecht, MD –Chairman of Medicine Charles Hemenway, MDCharles Hemenway, MD –Pediatrics Hematology/Oncology Karen Kiley, APN, AOCNKaren Kiley, APN, AOCN –Bone Marrow Transplant Cindi Laporte, RNCindi Laporte, RN –Pediatrics Inpatient Manager Sara Linton, PharmDSara Linton, PharmD –Medication Safety Specialist Ricarchito Manera, MDRicarchito Manera, MD –Pediatrics Hematology/Oncology Agnes Natonton, RN, OCNAgnes Natonton, RN, OCN –Research Oncology Nurse Janet Palutsis, RNJanet Palutsis, RN –Manager CBCC Ceil Petrowsky, RNCeil Petrowsky, RN –Research Nurse Manager Ronald Potkul, MDRonald Potkul, MD –Gynecology Surgery Marcus Quek, MDMarcus Quek, MD –Urology Surgery Richard Ricker, RPhRichard Ricker, RPh –Director of Pharamcy Twana Rundle, RN, OCNTwana Rundle, RN, OCN –Clinic Oncology Nurse CBCC Michele Sumner, RNMichele Sumner, RN –Manager Homer Glen Oncology Heather Wojtecki, RNHeather Wojtecki, RN –Manager BMT Rachel Wolfberg, PharmDRachel Wolfberg, PharmD –Pharmacy Manager Miriam Volle, APN, OCNMiriam Volle, APN, OCN –Bone Marrow Transplant

3. Confidential: Quality Improvement Material Project Aim The newly formed multidisciplinary Chemotherapy QI Committee used the Failure Mode and Effects Analysis (FMEA) tool developed by the Institute for Healthcare Improvement, to proactively identify potential errors which could occur in the current chemotherapy workflow. 42 steps in the process were examined.

4. Confidential: Quality Improvement Material Failure Mode and Effects Analysis (FMEA) Define all steps in the process Identify “failure modes” –What realities of daily practice might cause the process to fail? Define impact of failure mode on overall process –Numeric scores: Occurrence, Severity, Detection Make recommendations for actions to prevent failures

5. Confidential: Quality Improvement Material Format and Scoring Institute for Healthcare Improvement (IHI) format for FMEAInstitute for Healthcare Improvement (IHI) format for FMEA ScoringScoring –Occurrence – rate likelihood that failure will occur 1 (remote) to 10 (very high)1 (remote) to 10 (very high) –Detection – rate likelihood that failure would be detected if it occurred 1 (very high) to 10 (remote)1 (very high) to 10 (remote) –Severity – rate severity of failure if not detected 1 (no effect) to 10 (terminal injury or death)1 (no effect) to 10 (terminal injury or death)

6. Confidential: Quality Improvement Material Format and Scoring Risk Priority Number is the scoreRisk Priority Number is the score –O x S x D = RPN RPN calculated for each failure mode and for each stepRPN calculated for each failure mode and for each step –Each step may include multiple failure modes Use RPN to prioritize actionsUse RPN to prioritize actions

7. Confidential: Quality Improvement Material Findings RPN for entire process: 1831 The Steps with the highest RPNs were identified and action plans were developed. StepDescriptionFM’sTotal RPN 39RN Admin Chemo5456 7MD Reviews Alerts1120 6MD Signs Orders1105 40RN Monitors For Adverse Reaction1100 2MD Chooses Chemo Regimen299 5MD Verifies Orders798 41RN Regularly Checks Infusion196 28Tech Injects Med Into Bag190

8. Confidential: Quality Improvement Material Findings with Action Plans Step ActionOutcome/Monitoring 39. RN administers ChemoImplemented 2 RNs at the bedside verifying correct rate and connection. Dual signature required in MAR. Implemented in March 2008. Ongoing monitoring in Chemo QI Committee 7. MD reviews EPIC alertsDecreased alerts appearing in EPIC.Completed. 6. MD Signs OrdersRN double checking for signed orders. If unsigned orders identified and no MD visit prior to chemotherapy appointment, MD is paged prior to patient arriving to sign orders. Discussed at Heme/Onc Division Meeting February 2008. Ongoing monitoring in Chemotherapy QI 40. RN to monitor for adverse reactions Implemented prior to FMEA- standing orders for anaphylactic/hypersensitivity medications at the bedside, and RNs remain at bedside for 1 st 15 minutes of Paclitaxel. Reactions managed appropriately. No errors reported with this step.

9. Confidential: Quality Improvement Material Findings with Action Plans Step ActionOutcome/Monitoring 2. MD chooses chemotherapy regimen/evaluates previous treatment plan. Reevaluate Beacon protocol titles with physician input. Discussed physicians selecting wrong treatment plan at Heme/Onc Division Meeting in February 2008. No changes to be made at current time. Future Beacon upgrade will allow for more precise protocol titles. 5. MD verifies completed treatment plan Height and weight to be recorded only in metric. Fewer doses defaulting in Beacon forcing physician to manually enter doses. Ongoing monitoring. 41. RN performs regular checks of infusing medications Identified PhaSeal disconnection issues. Non-vesicant therapy checking minimally every 2 hours. Vesicant therapy via port, checking every hour. Closed system products investigated. New PhaSeal connector to be available in 2009. Ongoing monitoring. 28. Tech draws up medication and injects into bag Pharmacist now verifies drug volume prior to dilution. Additional verification step added in pharmacy.

10. Confidential: Quality Improvement Material Findings Continued ongoing collection of near misses and actual errors during FMEA process. The retrospective data collected indicate steps 2, 7, 28, 39, 40 and 41 had rare occurrences of near misses prior to the institution of the action plans and still remain rare.

11. Confidential: Quality Improvement Material Findings The retrospective data on step 5 has a possible 2009 downward trend. The retrospective data on step 6 has shown significantly improved. The retrospective data collected indicated different steps having reported near misses. A new FMEA is started in 2009, the committee used current occurrence data obtained retrospectively for more accurate RPNs.

12. Confidential: Quality Improvement Material May - 08 Jun - 08 Jul - 08 Aug - 08Sep - 08 Oct - 08 Nov - 08Dec - 08 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 UCL = 0.44 Mean = 0.17 New physicians Emphasis on increased reporting from all areas

13. Confidential: Quality Improvement Material 0.06 0.08 0.10 0.12 0.14 0.16 UCL = 0.12 Mean = 0.03 New physicians Pilot to investigate unsigned orders

14. Confidential: Quality Improvement Material Next Steps Started new FMEA in March 2009 Incorporated more proactive time in our Chemotherapy QI meeting to work on action plans Continue providing feedback from the committee to areas involved in chemotherapy process